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A study of low-dose interleukin-2 (aldesleukin) treatment in patients with early Alzheimer's Disease

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with early Alzheimer Disease, a progressive brain disorder that affects memory and thinking skills. The study evaluates a new treatment approach using aldesleukin (also known as ILT-101), which is a type of protein that can influence the immune system. The medication will be administered through cutaneous (skin) injections along with sodium chloride solution.

The purpose of this research is to determine if this treatment can slow down the progression of Alzheimer Disease compared to placebo over an 18-month period. The study involves regular treatment visits where participants receive either the study medication or placebo through skin injections. The treatment period lasts for 21 days, during which patients receive carefully controlled doses of the medication.

During the study, participants will be monitored by healthcare professionals to track changes in their condition. The treatment involves the use of Proleukin, which contains the active substance aldesleukin, administered as an injectable solution. Participants will need to attend multiple clinic visits throughout the study period for treatment administration and evaluation of their condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    You will undergo an initial evaluation to confirm your eligibility for the study. This includes verifying that you have a Clinical Dementia Rating Scale score of 0.5 or 1.

    A caregiver who will attend your clinical visits must accompany you.

  2. Step 2

    Treatment administration

    The treatment involves two medications: PROLEUKIN (aldesleukin) and sodium chloride solution.

    Both medications will be administered through skin application (cutaneous use).

    Your caregiver must be present or available for contact during each treatment visit.

  3. Step 3

    Regular monitoring visits

    You will attend multiple clinical follow-up visits throughout the study period.

    During these visits, your cognitive function will be evaluated.

    The study continues until December 2026, with a final follow-up period extending to June 2027.

  4. Step 4

    Final assessment

    The main measurement of the study will be the change in your Clinical Dementia Rating after 18 months.

    Your overall progress will be compared between the start and end of the treatment period.

Who can join the trial?

12 criteria

  • Must be over 18 years old
  • Must have a progressive memory loss condition that may include other thinking difficulties, confirmed by special tests of brain fluid
  • Must have a brain MRI scan that supports the diagnosis
  • Must have mild memory and thinking problems as measured by a special rating scale (CDR score of 0.5 or 1)
  • If taking antidepressants or memory medications, must be on stable doses for at least 1 month before joining the study
  • Must have a caregiver who:
    • Lives with the patient or has regular contact
    • Can attend important study visits
    • Can help ensure study procedures are followed
    • Can report on the patient's condition
    • Must have good enough vision and hearing to complete memory and thinking tests
    • Must be able to give written informed consent to participate
    • Must have French social security and be fluent in French language

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 85 years
  • Any condition that could interfere with the safety of the study medication
  • Participation in another clinical trial within the last 30 days
  • History of severe allergic reactions to medications
  • Significant neurological disorders other than Alzheimer's Disease (conditions affecting the brain and nervous system)
  • Severe psychiatric conditions (mental health disorders that require ongoing treatment)
  • Unstable medical conditions that require frequent medication changes
  • History of cerebrovascular disease (problems with blood vessels in the brain)
  • Severe liver or kidney dysfunction
  • Pregnancy or breastfeeding
  • Unable to comply with study procedures or follow-up visits
  • Use of prohibited medications that might interact with the study drug
  • Alcohol or substance abuse within the past year
  • Inability to provide informed consent
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Investigated drugs

Interleukin-2 (IL-2) is a naturally occurring protein in the body that helps regulate the immune system. In this trial, it is used in low doses as an immunotherapy treatment. It works by modulating the immune response, which may help slow down the progression of early Alzheimer's Disease. IL-2 therapy aims to reduce inflammation and potentially protect brain cells from damage.

What is already known about the treatment

Interleukin-2 (IL-2) - A naturally occurring protein-based medication administered through subcutaneous injection that plays a crucial role in regulating immune system responses. In this clinical trial, low-dose IL-2 is being investigated as a potential treatment for early-stage Alzheimer's Disease, representing a novel immunomodulatory approach to addressing neurodegenerative conditions. The medication works by stimulating the growth and activity of specific immune cells, particularly T-cells, which may help in reducing inflammation and potentially slowing down the progression of Alzheimer's Disease. IL-2 belongs to the class of biological response modifiers and has been previously approved for use in certain types of cancer treatment, though its application in Alzheimer's represents an experimental use under clinical investigation.

Investigated diseases

Alzheimer's Disease - A progressive brain disorder that slowly destroys memory, thinking skills, and the ability to carry out simple tasks. It begins with mild memory loss and confusion, which gradually becomes more severe over time. The disease causes brain cells to degenerate and die, leading to a continuous decline in thinking, behavioral and social skills. Changes in the brain may begin a decade or more before memory and other cognitive problems appear. People may experience difficulty remembering recent events or conversations in early stages, while later stages can affect language, reasoning, and basic daily functions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516565-36-00Protocol codeD20-P012Estimated enrolment45 patientsSponsorGroupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).